510(k) Report

Devices descending from K854801

56 later devices reach MS-189 Muscle Stimulator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K952273Handmaster NMS1Neuromusclar Electrical Stimulation Systems, Ltd.199655—
+2K031900HandmasterNess-Neuromuscular Electrical Stimulation Systems200335—
+2K022776Ness SystemNess-Neuromuscular Electrical Stimulation Systems200217—
+2K012823Modification to HandmasterNess-Neuromuscular Electrical Stimulation Systems20010—
+2K982482Handmaster NMS1N.E.S.S. Nuromuscular Electrical Stimulation Syst199854—
+3K103343L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left)Bioness, Inc.201115—
+3K080950Stiwell MED4Otto Bock, Austria GmbH200934—
+3K024279Ness Children SystemNess-Neuromuscular Electrical Stimulation Systems20030—
+4K243828Cionic Neural Sleeve (NS-200)Cionic, Inc.20250—
+4K232786Stimulation System (PA series, PR series, S series and Q series)Edan Instruments, Inc.20240—
+4K230701Stim2GoPAJUNK GmbH Medizintechnologie20230—
+4K210002Stella BioEgzotech Sp. Z O. O.20211—
+4K202648Biofeedback Nerve and Muscle StimulatorShenzhen Konmed Technology Co., Ltd.20202—
+4K200088g.Estim FESG.Tec Medical Engineering GmbH20200—
+4K201290Medline DeNovo 4Pro Electrical Stimulation DeviceMedline Industries, Inc.20202—
+4K162407L300 Go SystemBioness, Inc.20179—
+4K141812Mygait Stimulation SystemOtto Bock Healthcare Products GmbH20151—
+4K123972Walkaide SystemInnovative Neurotronics, Inc.201314—
+4K110179IncontrolIncontrol Medical, LLC201221—
+5K243079NeuroTrac® MyoPlus Pro (MYO120U)Verity Medical, Ltd.20250—
+5K241488TrainFES AdvanceTrainfes20250—
+5K222201Biological Feedback and Stimulation SystemMedlander Medical Technology, Inc.20220—
+5K220161Biofeedback Nerve and Muscle StimulatorShenzhen Konmed Technology Co., Ltd.20220—
+5K213043Levator Elite (Model LE9011)Shenzhen Dongdixin Technology Co., Ltd.20220—
+5K202110MStim Drop Model: LGT-233Guangzhou Longest Science & Technology Co., Ltd.20210—
+5K173682L300 Go SystemBioness, Inc.20187—
+5K163288Pelvifine Pelvic Muscle TrainerShenzhen Konmed Technology Co., Ltd.20180—
+5K162718Foot Drop System (Model XFT-2001D)Shenzhen Xft Medical Limited20171—
+5K142369Urinary Incontinence SystemGuangzhou Finecure Medical Equipment Co.,Ltd20150—
+5K150183ApexMIncontrol Medical, LLC20153—
+5K150180InToneIncontrol Medical, LLC20150—
+5K141158APEXIncontrol Medical, LLC20149—
+5K140886Walkaide SystemInnovative Neurotronics, Inc.201410—
+5K134020IntonemvIncontrol Medical, LLC201410—
+5K133826IntonemvIncontrol Medical, LLC20140—
+6K230997EvoWalk 1.0 SystemEvolution Devices, Inc.20230—
+6K193276Nerve and Muscle StimulatorShenzhen Xft Medical Limited20200—
+6K182022ApexMVIncontrol Medical, LLC20191—
+6K190285L300 Go SystemBioness, Inc.20195—
+6K181497HPM-6000UFBTL Industries, Inc.20186—
+6K142506TensCare KegelFitTenscare, Ltd.20154—
+7K262353BTL-299-FBTL Industries, Inc.20260—
+7K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer…Hunan Accurate Bio-Medical Technology Co., Ltd.20260—
+7K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)Pontemedag20260—
+7K251026Regenesis EMS ChairTrinity Medical Solutions20250—
+7K241516BTL-398BTL Industries, Inc.20250—
+7K230780MFG-05Zimmer Medizinsysteme GmbH20230—
+7K230767Pelvic Floor Muscle StimulatorNanjing Vishee Medical Technology Co., Ltd.20230—
+7K213622Cionic Neural Sleeve NS-100Cionic20222—
+7K200262L100 Go SystemBioness, Inc.20200—
+7K191312Perfect PFETenscare, Ltd.20193—
+7K191587L360 Thigh SystemBioness, Inc.20190—
+8K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd.20260—
+8K251760Well-Life Incontinence Stimulation System (WL-2405i (P))Well-Life Healthcare, Ltd.20260—
+8K230983Unicare (K-UNICARE-USA)Tenscare, Ltd.20230—
+8K221823Cionic Neural Sleeve NS-100Cionic20221—